Sustainable Habits for Encouraging Even Teen Sleep

Sleep Clinical Trial

— SHEETS  

Official title:

Sustainable Habits for Encouraging Even Teen Sleep (SHEETS): A Digital Intervention to Enhance Sleep and Psychiatric Health in Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05378373
• Other study ID #: Pro00109013
• Secondary ID: 1R34MH128440-01
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: Shubha Parekh
• Phone: (919)385-0824
• Email: shubha.parekh[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will examine the feasibility, acceptability, and effectiveness of two digital sleep interventions in improving sleep regularity and psychiatric health during a critical period of adolescence.

Description:

This study will be testing two digital sleep health interventions for adolescents. Adolescents in both conditions will receive sleep education-related content. This project also uses an innovative digital platform and wearable sensors to deliver feedback.

The purpose of this research study is to evaluate a 6-week digital sleep intervention to promote healthy sleep patterns. The study will be broken up into two phases: Phase 1: Focus group participation. Participants and their guardian will be asked to participate in a focus group to get their thoughts/opinions on the intervention. Phase 2: Participants and their guardian will be asked to come to 4 different study visits: baseline, post-intervention, 3 month and 6 month follow up. Participants will be asked to complete questionnaires about demographics, psychiatric health, and sleep patterns. The participants will be asked to wear an ActiGraph watch for 24hrs/day for a week for 4 separate weeks, a Garmin for the duration of the 6-week intervention and keep a sleep diary through an online program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 14 Years

Eligibility

Inclusion Criteria:

• ages 12-14 years

• parent concern on the routines/consistency subscale of the Pediatric Sleep Practices Questionnaire, indicating poor sleep practices (score of 2) in at least one of the following: bedtime consistency, wake time consistency, and bedtime routines;

• ability to speak, read and write in English

• access to internet and smartphone device with capacity to download intervention App (iOS and Android)

• valid email address

• ability to follow written and verbal instructions

• ability and willingness to comply with study procedures.

Exclusion Criteria:

• diagnosed sleep disorder

• psychiatric disorder under treatment (medication and/or therapy) or intellectual disability

• chronic pain condition interfering with sleep

• substance use disorder

• use of medication for sleep (prescription or over-the-counter)

• has a sibling also enrolled/participating in the same study

Related Conditions & MeSH terms

• Sleep

Intervention

Behavioral:
• Garmin, Pattern Health App
Wearable sensors will deliver individualized feedback to participants according to their assigned intervention

Locations

Country	Name	City	State
United States	Duke Children's Primary Care North Durham	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Sleep Regularity Index (SRI)	A measure of sleep regularity collected continuously over 7 days via Actigraphy. The SRI is calculated as the proportion of pairs of time points 24 hours apart that have matching sleep/wake status	baseline, 6 weeks, 3 months, 6 months
Primary	Feasibility as measured by Recruitment rate	The number of participants consenting (and assenting) divided by the number who were invited.	6 months
Primary	Feasibility as measured by Retention Rate	The number of participants who return for each sleep regularity assessment divided by the number who were eligible upon completion of the baseline assessment.	6 months
Primary	Acceptability as measured by activity completion	The number of participants who complete all weekly sessions divided by the total number of weekly sessions.	6 months
Secondary	Change in Self-Reported Sleep Health	Self-reported sleep will be assessed via the PROMIS pediatric sleep survey, a 5-point Likert scale ranging from Never to Always. Lower scores indicate better outcomes.	baseline, 6 weeks, 3 months, 6 months
Secondary	Change in Adolescent Reported Psychiatric Health	As measured by the Youth Self Report, a 112-item questionnaire, with a 3-point Likert scale ranging from Not True to Very True. Lower scores indicate better outcomes.	baseline, 6 weeks, 3 months, 6 months
Secondary	Change in Parent Reported Psychiatric Health	As measured by the Child Behavior Checklist, a 112-item questionnaire, with a 3-point Likert scale ranging from Not True to Very True. Lower scores indicate better outcomes.	baseline, 6 weeks, 3 months, 6 months
Secondary	Sleep Regularity Index (SRI) as measured by Garmin	A measure of sleep regularity collected continuously over 6 weeks via Garmin. The SRI is calculated as the proportion of pairs of time points 24 hours apart that have matching sleep/wake status	6 weeks